510(k) Report

Devices descending from K050447

5 later devices reach Performa Adult Hollow Fiber Membrane Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102109Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy…Eurosets S.R.L20114—
+2K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L20153—
+3K202510AMG PMP InfantEurosets S.R.L20210—
+3K202206AMG PMP PediatricEurosets S.R.L20211—
+4K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.20260—